Offshore Manufacturing
Some industry observers feel that disposables could have an impact on where biopharmaceuticals are made geographically. "In
developing countries that may be capable of producing biogenerics, as the worldwide need for large molecule therapeutics grows,
some active pharmaceutical ingredient (API) manufacturing will likely move offshore," said Lee Karras, senior vice president
of pharmaceutical operations at AAIPharma. "This situation is already the case in the small-molecule arena. As such, you will
eventually see large multiproduct facilities overseas that rely on disposable technology, especially in multiproduct equipment
trains, so that their assets are best utilized and production costs minimized."
Improved Storage in Space-constrained Environments
Dedicated compounding tanks used in parenteral manufacturing in a multiproduct facility need to be stored when not in use
in an area that is clean and free of potential bioburden contamination. Disposables, in contrast, store more easily and efficiently
than portable dedicated tanks. "Companies are moving toward storage into clean areas with high-efficiency particulate air
(HEPA) control," says Karras. "These areas are costly to build and maintain. Disposable bags and tank liners can be stored
in double or triple over-wrapped bags, flat and stacked in a lower cost general warehouse. When needed, the over-wrapped bags
or liners can be taken into a clean area and unbagged in succession as they are moved into cleaner areas ultimately exposing
the bags and liners to only the desired level of cleanliness."
Greater Flexibility for Small-scale Operations
Disposables will become an enabling technology for the production of small-scale products, according to Roland A. Heinrich,
PhD, vice president of bioprocess R&D at Millipore. "Flexible production opportunities in small to medium scale will give
opportunities to small start-ups to commercialize earlier...or allow them to negotiate better with their large manufacturing
partners," he says.
Personalized Medicine and Disposables
The nature of cell and gene therapies make disposables a logical manufacturing approach. Visti Wedege, manager of cell culture
products at Nunc A/S, says, "Disposables are becoming a critical component in achieving the promise of safety in personalized
medicine. Disposables will ultimately provide a safe patient manufacturing and delivery solution by minimizing the potential
for cross contamination. For the same reasons, disposables will likely prove to be a more cost-effective approach because
the responsibility for cleaning and validation will move out of the clinic, as part of a cell therapy procedure, and to the
component manufacturer." Bioreactors and other disposable elements produced under current good manufacturing practices (cGMP)
enhance the overall convenience and safety of cell therapy procedures.
More Multiproduct Facilities
Millipore's Heinrich also considers the application of disposable technology in multiproduct manufacturing settings a prevalent
trend. Not all products need large volume manufacturing. Hence, multi-product manufacturing in one suite using disposables
will allow high capacity utilization. In addition to multiproduct facilities, Heinrich envisions modular manufacturing done
in a "rapid factory" based on disposable, prevalidated units that can be deployed quickly. These would be capable of producing
products safely in areas without proper infrastructure; for example, they could be used to manufacture vaccines in underdeveloped
regions.
Lower Costs for Additional Capacity
Both contract manufacturing organizations (CMOs) and biotherapeutic manufacturers will be able to squeeze more capacity into
the same utility infrastructure by using disposables. "Some facilities may be able to double the capacity without impacting
the majority of the utilities in the coming years if disposables are deployed in unit operations," says Tim Vickers, president
of Project Planning and Delivery, Inc. (PP&D). "This will help keep incremental add-on costs lower than if they just added
steel tank manufacturing capacity."
Reduced Seed Train Requirements
Vickers also sees seed trains as an area that will impact production. These trains now comprise disposable components only.
Expect as much as 2,000–3,000 L to be optimal use, as the ergonomic disadvantages increase and the net present value advantages
diminish at larger scales.
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